• HanAll has initiated a Phase III VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye based on the findings from the previous Phase III VELOS-3 study.
• Tanfanercept demonstrated statistically significant improvement on the secondary outcome measure, Schirmer testing of tear volume, from the previous Phase III study.
• The top-line data for the Phase III VELOS-4 study is expected in the second half of 2025.

 HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, announced the initiation of a Phase III VELOS-4 trial evaluating the efficacy and safety of tanfanercept, a novel, topical anti-inflammatory treatment in participants with moderate to severe dry eye disease (DED).

Dry eye disease is a chronic multifactorial disease with a prevalence estimation of 14.5% for the US population^([1]). The available treatments for DED often prove insufficient in managing symptoms, occasionally resulting in visual impairment and ocular inflammation, alongside a low response rate that contributes to discontinuation. Thus, there is an unmet clinical need to develop mechanism-based and disease-modifying treatments.

Tanfanercept is a potentially first-in-class topical anti-inflammatory treatment targeting tumor necrosis factor (TNF) for the treatment of DED, co-developed with Daewoong Pharmaceutical. TNF is a major cytokine mediating inflammation in DED. Tanfanercept is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment with strong affinity for TNF and resistance to degradation by proteinases.

The Phase III VELOS-4 trial leverages key insights from the concluded Phase III VELOS-3 study. In VELOS-3, tanfanercept showed a statistically significant improvement in the secondary efficacy endpoint of tear volume measured by unanesthesized Schirmer testing in the group of patients treated with tanfanercept compared to the vehicle group at week 8 (p=0.002). Furthermore, a post hoc analysis revealed that a noteworthy proportion of participants in the tanfanercept group (13%) exhibited a Schirmer test improvement of at least 10mm from baseline at week 8, which was also statistically significant (p=0.011) compared to the vehicle group (4%). VELOS-2, a preceding Phase III study, also demonstrated a consistent improvement in Schirmer testing in an ad hoc analysis that subset the population to be similar to that of patients studied in VELOS-3.

The 2020 FDA Draft Guidance on Dry Eye Drug Development includes the proportion of participants with a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval.

"Initiating the Phase III VELOS-4 trial marks a significant milestone in our commitment to addressing the unmet needs of patients suffering from dry eye disease. With tanfanercept's promising results in earlier studies and its innovative mechanism targeting TNF, we are hopeful that this novel treatment will offer new hope and relief to those affected by this debilitating condition," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

Top-line data from the Phase III VELOS-4 trial is anticipated in the second half of 2025.